Status:
COMPLETED
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Lead Sponsor:
Que Oncology
Conditions:
Vasomotor Symptoms (VMS)
Eligibility:
FEMALE
30-70 years
Phase:
PHASE1
Brief Summary
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
Detailed Description
Vasomotor symptoms are significant in postmenopausal women with the most effective medications for relief being hormonal preparations. Non-hormonal medications have demonstrated efficacy but at a far ...
Eligibility Criteria
Inclusion
- Be a female of any race between the ages of 30-70 years.
- History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.
- Naturally menopausal: ≥ 12 months spontaneous amenorrhea or \> 6 but \< 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of \> 40 mIU/mL (Milli-international Units Per Milliliter).
- Surgically menopausal with an FSH level \> 40 mIU/mL.
- Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.
- Able to read, understand and complete the required subject diary.
- Willing and able to complete the daily subject diary, attend all study visits, and participate in all study procedures, including PK blood draws.
Exclusion
- Childbearing potential, including pregnancy, or lactation.
- Undiagnosed abnormal genital bleeding.
- Significant day-to-day variability in hot flushes.
- Participation in another clinical trial within 30 days prior to screening or during the study.
- Legal incapacity or limited legal capacity.
- Chronic renal (serum creatinine \> 2.0 mg/dL) or hepatic disease \[SGPT (ALT) or SGOT (AST) \> 2X normal limits\].
- Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122.
- Untreated overt hyperthyroidism.
- Use of thyroid medication of less than 12 weeks on a stable dose.
- Any clinically important systemic disease in the judgement of the investigator.
- Inability to complete all study visits and study assessments for scheduling or other reasons.
- Any other reason which in the investigator's opinion makes the subject unsuitable for a clinical trial.
- Abnormal laboratory findings including:
- Hematocrit \< 30% or hemoglobin \< 9.5 gm/dL
- Fasting blood sugar \> 140 mg/dL
- Fasting serum triglycerides \> 300 mg/dL
- Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of normal (a subject will not be excluded if a second measurement is less than twice the upper limit of normal)
- Creatinine \> 2.0 mg/dL
Key Trial Info
Start Date :
January 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04080297
Start Date
January 10 2014
End Date
July 28 2014
Last Update
February 28 2020
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